(166 days)
Ivivi K070541
Not Found
No
The document describes a non-invasive shortwave diathermy device and does not mention any AI or ML components or capabilities.
Yes
The device is described as a "medical device" intended for "palliative treatment of post-operative pain and edema," which are therapeutic applications.
No
Explanation: The intended use states "palliative treatment of post-operative pain and edema," indicating a therapeutic rather than diagnostic purpose. The device description also focuses on applying electromagnetic energy for treatment.
No
The device description explicitly states it is a "portable (battery operated) non-invasive shortwave diathermy medical device" that applies electromagnetic energy via an applicator coil and OrthoPods. This clearly indicates the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the palliative treatment of post-operative pain and edema in superficial soft tissue. This is a therapeutic use, not a diagnostic one.
- Device Description: The device applies electromagnetic energy to the body for treatment. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The device is a therapeutic medical device used for pain and edema management.
N/A
Intended Use / Indications for Use
Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue. The OrthoCor Knee System Basic is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
ILX
Device Description
The OrthoCor Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Superficial soft tissues (knee)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed physician/chiropractor
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Ivivi K070541 (Torino II)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
0
KO91996
DEC 1 5 2009
510(k) Summary
| SUBMITTED BY: | ORTHOCOR MEDICAL, Inc.
1000 Westgate Drive, Suite 243,
Minneapolis, MN 55114
Registration: Awaiting Assignment |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 22, 2009 |
| CONTACT: | Advanced Medical Consortium
9907 Oakleaf Way
McCordsville, IN 46055
Tel: 651-641-2829 |
| TRADE NAME: | OrthoCor Knee System |
| COMMON NAME: | Shortwave Diathermy |
| CLASSIFICATION NAME: | Diathermy, Shortwave, For Use Other Than Applying
Therapeutic Deep Heat |
| DEVICE CLASS: | Class III |
| PRODUCT CODE: | ILX, 21 CFR 890.5290(b) |
| PREDICATE: | Ivivi K070541 (Torino II) |
DEVICE DESCRIPTION
The OrthoCor Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i.e., by athermal means. The OrthoCor Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power
INTENDED USE
- Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft . tissue.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below.
COMPARISON TO PREDICATE DEVICES(s)
The OrthoCor Medical OrthoCor Knee System has the same intended use, target population, clinical setting, and technology as its predicate devices.
1
| Device Features | Predicate
IVIVI Torino II K070541 | OrthoCor Knee System |
|----------------------------|--------------------------------------|-----------------------------------------|
| Technology | Deposit athermal RF energy in tissue | Deposit athermal RF energy in
tissue |
| Anatomical sites | Superficial soft tissues | Superficial soft tissues (knee) |
| Practitioner | Licensed physician/chiropractor | Licensed physician/chiropractor |
| Portable | Yes | Yes |
| How Energy Deposited | Induction (coil applicator) | Induction |
| Carrier Frequency | 27.12 MHz | 27.12 MHz ± 5% |
| Burst duration | 2msec | 2msec |
| Burst frequency-- | 2Hz | 2Hz |
| Energy Deposited Per Pulse | 6.5 µWs/cm³ | 6.5 µWs/cm³ |
| Electrical safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Electromagnetic safety | Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Power required | Battery or Mains | 3V-4.2V DC (battery) |
STANDARDS MET
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic . Safety and Essential Performance
- IEC 60601-1-2 Medical Electrical Equipment- Part 2: General Requirements for Safety-. Collateral Standard: Electromagnetic Compatibility- Requirements and Tests
CONCLUSION
OrthoCor Medical, Inc. believes that the OrthoCor Knee System is substantially equivalent to the predicate device based on intended usage, technology comparison and system performance.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 5 2009
OrthoCor Medical, Inc. % Advanced Medical Consortium Ms. Ines Burgos 9907 Oakleaf Way McCordsville, IN 46055
Re: K091996
Trade/Device Name: OrthoCor Knee System Basic Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX Dated: November 27, 2009 Received: December 3, 2009
Dear Ms. Burgos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Ines Burgos
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jonata
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Form
510(k) Number:
Device Name: OrthoCor Knee System Basic
Indications for Use: The OrthoCor Knee System Basic is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.
Prescription Use X 21CFR 801, Subpart D
OR Over-the-Counter Use 21CFR 801.109
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hauley M. Dayle FOR M. MELKERSON
Division Sign Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091996